MECLIZINE HYDROCHLORIDE

Product NDC: 63629-2432
11-digit product format: 636292432
Labeler code: 63629
Product ID: 63629-2432_95ff1d32-94ad-4ef2-81b1-eff43157df3f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Meclizine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040659
Marketing category: ANDA
Marketing start: 2010-06-04
Marketing end: 2026-10-31
Substance: MECLIZINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040659-001	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA		2010-06-04
A040659-002	MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA		2010-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040659-001	AA
A040659-002	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040659-001	MECLIZINE HYDROCHLORIDE	12.5MG	TABLET / ORAL	AA	2010-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040659-002	MECLIZINE HYDROCHLORIDE	25MG	TABLET / ORAL	AA	2010-06-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040659-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040659-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040659-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040659-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040659-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040659-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040659-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040659-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040659-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040659-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040659-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040659-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040659-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040659-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040659-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040659-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040659-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040659-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040659-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040659-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040659-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040659-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040659-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040659-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040659-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040659-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040659-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040659-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040659-002	AA	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: MECLIZINE HYDROCHLORIDE

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MECLIZINE HYDROCHLORIDE	12.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HDP7W44CIO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
995624	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6c66ee38-10bb-4559-9d2f-51e6d6f091ee	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ac6963c4-31c6-325f-ee58-83a0a06597ad	Product name	5	20221206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-2432-1	MECLIZINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000		103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2432-1	EA - Each	63629-2432	0ccd2cd5-db64-41c2-b1db-260f2bbf7c58	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2432	MECLIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 1 package rows	20231208_6c66ee38-10bb-4559-9d2f-51e6d6f091ee.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	REMEDYREPACK INC.	ba2fb6de-af86-4c05-9018-135e1f8594f9	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Northwind Health Company, LLC	c443873a-2e89-43b2-b145-dde3dadf7bc0	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
Meclizine Hydrocloride	MECLIZINE HYDROCLORIDE	QPharma Inc	aa0fb895-a867-4482-9bc2-16eee8bfaaa0	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	522b55a2-313c-45e8-b1be-07746ada5b0a	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Bryant Ranch Prepack	f43bf077-3f29-48ec-8ca8-eb294dbf2001	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6dd657ba-46dc-4106-9f6a-dfa0ecf85752	2025-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	2025-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659 ndc (product): 63629-2432
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Jubilant Cadista Pharmacuticals Inc.	9350fefc-9c00-182c-c3a9-044d4a40856f	2025-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	NuCare Pharmaceuticals,Inc.	64a508ae-768a-2fba-e053-2991aa0ac42d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Proficient Rx LP	6a8cbc12-0725-4462-bb71-0b18cefc19e7	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Proficient Rx LP	f574e123-8db7-4e3d-a0ee-e4e1f04ff146	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCLORIDE	Asclemed USA, Inc.	5c70e61b-a1e6-4981-92e2-1050cee08baa	2020-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659
MECLIZINE HYDROCHLORIDE	MECLIZINE HYDROCHLORIDE	Bryant Ranch Prepack	53f410fd-104c-42c1-9740-6f48ffbc974f	2020-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040659 application number: ANDA040659

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HDP7W44CIO	MECLIZINE HYDROCHLORIDE	31884-77-2	MECLIZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
995624	meclizine HCl 12.5 MG Oral Tablet	PSN	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	103
995624	meclizine hydrochloride 12.5 MG Oral Tablet	SCD	6c66ee38-10bb-4559-9d2f-51e6d6f091ee	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2432-1	63629243201	1000 TABLET in 1 BOTTLE (63629-2432-1)	1000 tablet	2021-02-25	2026-10-31	No	No	Current